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NCT05660811Not yet recruitingPhase 4

Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure – Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study – PILOT

Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure – Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study – PILOT

Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

1. To compare safety and efficacy of early DAPT discontinuation at 30 days postprocedure and continuation of SAPT up until 6-month vs 6 months of postprocedural DAPT in patients with end-stage renal disease on chronic dialysis (randomized comparison) 2. To compare safety and efficacy of chronic SAPT beyond 6 months postprocedure vs discontinuation of all antiplatelet treatment 6 months after LAAC in patients with end-stage renal disease on chronic dialysis (nonrandomized comparison).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
80 (estimated)
First submitted
16 Oct 2024
Start date
28 Sept 2022
Lead sponsor
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
NCT number
NCT05660811
EU CT number
2024-516384-93-00
EudraCT number
2021-006127-17

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 80
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any indication to chronic antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion. 2. Indications to chronic anticoagulation 3. Known allergy to clopidogrel of acetylsalicylic acid 4. Diagnosis of coagulation disorders 5. Peridevice leaks greater than 5mm 6. Thrombus in the left atrium on the qualifying imaging of the left atrium 7. Life expectancy less than the duration of the trial due to noncardiovascular comorbidity 8. Enrollment into a competing trial using a non-approved devices or drugs - currently and up to 3 months prior to enrolment 9. Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.

Who the study is looking for

  • Successful percutaneous left atrial appendage occlusion with Amplatzer or WATCHMAN devices within 37 days prior to randomization 2. End-stage renal disease treated with chronic hemodialysis or chronic peritoneal dialysis 3. Age >= 18 yrs 4. Participant is willing to comply with all aspects of the protocol including the assigned treatment strategy and follow-up visits 5. The participant is willing to give written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandNot yet recruiting
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandNot yet recruiting
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
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ŁódźPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandNot yet recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandNot yet recruiting
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandNot yet recruiting
Szpitale Pomorskie Sp. z o.o.
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WejherowoPolandNot yet recruiting
Śląskie Centrum Chorób Serca w Zabrzu
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ZabrzePolandNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.